Abstract
BACKGROUND AND OBJECTIVE: Recombinant human bone morphogenetic protein-2 (rhBMP-2) has been extensively studied in preclinical, animal, and human studies and has been used widely in spine fusion surgery. Evidence demonstrates that fusion rates with rhBMP-2 are similar to or higher than those achieved with autologous bone graft. However, there have been concerns regarding the cost, optimal dosage, and potential complications of rhBMP-2 use in spine surgery. The objective of this paper is to provide a current review of the available evidence regarding rhBMP-2 and other bone graft substitutes used for spinal surgery. METHODS: We searched Ovid Medline, PubMed, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, American College of Physicians Journal Club, and Database of Abstracts of Review of Effectiveness for 2 studies regarding physiology of bone fusion in spine surgery, formulations and indications of rhBMP-2, cancer risk of rhBMP-2, and alternatives to rhBMP-2 published from 1965 to 2022 in English. KEY CONTENT AND FINDINGS: The debate regarding indications and cost effectiveness of rhBMP-2 is presented based on increasing data and use criteria. Here, we focus on the effectiveness and economic costs (both direct and indirect) of rhBMP-2 and alternative bone graft substitutes. Based on the cumulative literature, we provide recommendations for rhBMP-2 use in spine surgery. CONCLUSIONS: Based on our review of the literature, we recommend the following: (I) clear informed consent processes between surgeons and patients regarding current evidence of the benefits and risks of using rhBMP-2 and available alternative bone graft substitutes. (II) Consideration of rhBMP-2 for spinal fusion surgery (excluding anterior cervical procedures), especially adult spinal deformity (ASD) surgery, lumbar surgery for multilevel degenerative disease, revision surgery for pseudoarthrosis, and surgery in patients with a low-quantity or low-quality autograft. (III) Regulatory oversight of the type, volume, and dose of bone graft substitute (both per level and per procedure) to ensure appropriate indications, prevent excessive usage, and thereby enhance cost containment.